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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005252
Receipt No. R000006248
Scientific Title Candesartan/Hydrochlorothiazide Versus High-dose Candesartan for the Clinical Assessment of N-terminal pro-B Type Natriuretic Peptide Levels and Cardio-renal Protective Effects: A comparative study
Date of disclosure of the study information 2011/03/23
Last modified on 2016/04/15

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Basic information
Public title Candesartan/Hydrochlorothiazide Versus High-dose Candesartan for the Clinical Assessment of N-terminal pro-B Type Natriuretic Peptide Levels and Cardio-renal Protective Effects: A comparative study
Acronym J-CHANCE
Scientific Title Candesartan/Hydrochlorothiazide Versus High-dose Candesartan for the Clinical Assessment of N-terminal pro-B Type Natriuretic Peptide Levels and Cardio-renal Protective Effects: A comparative study
Scientific Title:Acronym J-CHANCE
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of high-dose candesartan and candesartan/hydrochlorothiazide on blood pressure and cardio-renal protection in hypertensive patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. The achievement rate of blood pressure targets measured at home (home BP) and at the outpatient department according to the Japanese Society of Hypertension (JSH) 2009 criteria
2. Changes in the levels of cardio-renal associated markers, inflammatory markers and glucose metabolism
Key secondary outcomes Changes in 24-h ambulatory blood pressure, lipids, microalbuminuria, uric acid, and serum potassium

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation YES
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 candesartan12mg
Interventions/Control_2 candesartan 8mg + hydrochroltiazide 6.25mg
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1. Age=>20 years
2. Hypertensive patients who did not achieve the target blood pressure of JHS 2009 criteria
3. Hypertensive patients treated with 8 mg/day of candesartan for more than 2 months
Key exclusion criteria 1. Patients with a history of hypersensitivity to the study drugs
2. Patients with a history of hypersensitivity to thiazide or thiazide-like diuretics
3. Patients with chronic renal failure (serum creatinine => 2.0 mg/dL)
4. Patients with anuria or on dialysis
5. Patients with acute renal failure
6. Patients whose levels of sodium and/or potassium are obviously low
7. Patients who are pregnant, possibly pregnant, or lactating
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Shimada
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL 03-3813-3111
Email shimakaz@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunoir Shimada
Organization Juntendo University School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo Bunkyo-ku, Tokyo 113-8421 Japan
TEL 03-3813-3111
Homepage URL
Email shimakaz@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine, Department of Cardiovascular Medicine
Institute
Department

Funding Source
Organization Juntendo University School of Medicine, Department of Cardiovascular Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Juntendo University Shizuoka Hospital
Juntendo University Urayasu Hospital
Juntendo University Nerima Hospital
Koto Hospital
Tobu Chiiki Hospital
Koshigaya Municipal Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 15 Day
Last modified on
2016 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006248

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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